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ERA Europe Transatlantic Regulatory Update Rome 2013 Self Regulation Officer – Klaus Parchent

ERA Europe Transatlantic Regulatory Update Rome 2013 Self Regulation Officer – Klaus Parchent. Transregulatory Update Rome 2013. AGENDA The ERA Europe Self Regulation Program General Pitfalls within advertising Requirements in advertising nutrition or cosmetics.

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ERA Europe Transatlantic Regulatory Update Rome 2013 Self Regulation Officer – Klaus Parchent

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  1. ERA Europe Transatlantic Regulatory Update Rome 2013 Self Regulation Officer – Klaus Parchent

  2. Transregulatory Update Rome 2013 AGENDA • The ERA Europe Self Regulation Program • General Pitfalls within advertising • Requirements in advertising nutrition or cosmetics

  3. Topic 1:The ERA-Europe Self Regulation Program Why do we do it? • Benefits for our industry: • Showing all stakeholders: Look, we are playing by the rules • Controlling the quality of our industry - but by ourselves • Defocusing of regulatory bodies • Winning trust at our customers (Shop with confidence) • Banning black sheep • Benefits for our members displaying the seal: • Showing that you are a trustworthy business partner • Displaying a Quality seal without additional cost • Getting an additional source of support in difficult areas • Having an intermediate step before an issue becomes a legal or a regulatory issue

  4. Topic 1: The ERA-Europe Self Regulation Program • What is the content of our commitment? • Content of commitments: • Fair, ethical and responsible trade. • Presenting products and services in a clear and honest way. • Complete and transparent pricing with no hidden costs. • Ensuring that customers can order without risk. • A proper and reliable returns policy. • Protecting customer data.

  5. Topic 1 – The ERA-Europe Self Regulation Program • What kind of issues are we expecting? • Typical consumer issues • Returns incl. money restitution • Warranty • Data protection • Typical issues from SRO or members • Product Claims • Presentation

  6. Topic 2: General Pitfalls within advertising • Commitment: Presenting products in a clear and honest way • Claims substantiation: • no deceptive implied claims • no omission of material information • Reference to scientific proof or tests only if existing and backing the claim • health or safety claims for products such as dietary supplements, drugs, diet and exercise products and medical devices require competent and independent scientific evidence and have to comply with EU-Health Claims Regulation

  7. Topic 2: General Pitfalls within advertising • Commitment: Presenting products in a clear and honest way • Demonstrations, testimonials and endorsements • true testimonials or endorsements supported by the relevant documentation. • demonstrations must not misrepresent any material feature or the product’s actual performance in real-life conditions. • Be careful with comparative tests and demonstrations of competing products • consumer testimonials must reflect honest opinions, findings, beliefs or experiences and be representative of the results to be expected by the average consumer. • endorsement from a professional or an expert should be supported by the relevant documentation, ie qualifications or proof of profession. • Testimonials should not be the only evidence to substantiate claims and any claim expressed must be supported by documentary evidence.

  8. Topic 3: Requirements in advertising nutrition and cosmetics • Nutrition products: • Specific legal environment: • EU Health Claims Regulation since 2007 • Aims: • High level of consumer protection and avoidance of competition hinderances • Content: • HC-Regulation takes care of commercial information referring to • Nutrition claims: „sugars-free“, „low fat“, „rich on Vitamine C“ and • Health claims: „reduces cholesterine“, „strengthens defensive forces“ • Consequences: • Preventive prohibition with possibility of approval; • claims have to be approved (formal approval-procedure), have to be taken out of the EU-Register or have to fulfill the requirements of the nutrient profiles (not yet published) • Regulation at least enables to make „risk-reduction-claims“ • Before the HC Regulation: everything was allowed which was not explicitly forbidden • After the HC Regulation: everything is forbidden which is not explicitly allowed

  9. Topic 3: Requirements in advertising nutrition and cosmetics Nutrition products: EU-register, published on Jan. 31, 2010: Out of 44.000 claims which have applied for approval, until now 2.102 claims have been authorized.

  10. Topic 3: Requirements in advertising nutrition and cosmetics • Cosmetics: • Specific legal environment: • EU Cosmetic Regulation 1223/2009, coming into effect on July 11th, 2013 • New requirements: • Responsible person – for each product, residence in EU • Nanomaterial ingredients – product registration 6 months before market entry • Animal testing ban – for products and ingredients • Notification portal – registering of each product • Safety report and Product information file – wider documentation • Access to information for the public – qualitative and quantitative composition

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